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CN-116327445-A - Annuloplasty device and method

CN116327445ACN 116327445 ACN116327445 ACN 116327445ACN-116327445-A

Abstract

The invention belongs to the technical field of medical appliances, and particularly relates to an annular repair appliance and a repair method. Wherein, the valve annulus repair apparatus includes a sleeve pipe and a plurality of anchor, still includes: and the shaping ring is made of a bendable and shaped shape memory material and is buried in the sleeve. The shaping ring is embedded in the sleeve, so that the sleeve has the shaping and tightening functions, the corresponding research and development cost of the locking component and the shearing catheter is saved, and the reliability and the application flexibility of the remodeled valve ring are improved. The semi-rigid annular contraction clinical effect can achieve the clinical effect similar to that of a surgical semi-rigid annular ring, and the surgical aim of small wounds and heart continuous jumping is met.

Inventors

  • YE JUN
  • ZHANG MEIHUI
  • LIANG YUCHEN

Assignees

  • CHENXING NANTONG MEDICAL DEVICES CO LTD
  • QICHEN SHANGHAI MEDICAL DEVICES CO LTD

Dates

Publication Date
20230627
Application Date
20230328
Priority Date
20230328

Claims (16)

  1. 1. An annuloplasty device comprising: a sleeve; the anchors are arranged on the sleeve and are sequentially arranged along the length direction of the sleeve; the shaping ring is made of a bendable and shaped shape memory material and is buried in the sleeve.
  2. 2. The annuloplasty device according to claim 1, wherein said sizing ring and said sleeve are integrally injection molded; and/or, the sleeve and the shaping ring adopt a C-shaped structure with a notch; and/or the sleeve is an elastic sleeve made of polyurethane or silica gel; and/or, the shaping ring is a nickel-titanium shaping ring made of nickel-titanium alloy materials; and/or, a plurality of developing rings are also arranged in the sleeve.
  3. 3. The annuloplasty device according to any of claims 1 to 2, wherein said sleeve has a plurality of protrusions along the circumference of the inner wall, said protrusions being located inside said sleeve, said protrusions having a socket for said anchor.
  4. 4. The annuloplasty device according to claim 3 wherein said anchor has a threaded aperture therein; the annuloplasty device further comprises a traction rope which sequentially passes through the threading holes of each anchor along the circumferential direction of the sleeve.
  5. 5. The annuloplasty device according to claim 4, wherein said anchor comprises: an anchor body; the anchor pin jacket is axially provided with a through hole, an internal thread in threaded connection with the anchor pin body is arranged in the through hole, and the anchor pin jacket is arranged in the insertion port; and the traction part is provided with the threading hole.
  6. 6. The annuloplasty device according to claim 5 wherein said threading aperture is located on a side facing the inside of said sleeve.
  7. 7. The annuloplasty device according to claim 5, wherein said anchor body comprises, in sequence: a connecting portion provided with a guide hole; the screw thread part is provided with external screw threads and is in threaded connection with the anchor bolt outer sleeve; an anchoring part which is a spiral rod; the annuloplasty device further comprises: the guide ropes are arranged on the corresponding guide holes in a penetrating mode.
  8. 8. The annuloplasty device of claim 7, further comprising an anchor driver operable to move along the guide line to the connection and to engage the connection in a circumferential direction to drive rotation of the connection.
  9. 9. The annuloplasty device according to claim 8, wherein said connecting portion is of polygonal configuration and extends upwardly from said threaded portion; the anchor driver includes: the clamping part is inserted on the connecting part along the guide rope and is clamped with the connecting part along the circumferential direction; the distal end of the driving tube is fixedly connected with the clamping part, and the driving tube is operably sleeved outside the guide rope and drives the clamping part to rotate.
  10. 10. The annuloplasty device according to claim 9, wherein said attachment portion comprises: the base is provided with a clamping groove along the axis direction, and the clamping groove is a polygonal clamping groove; the guide post is positioned in the clamping groove and is concentrically arranged along the base, and the guide post is provided with the guide hole; the clamping part is a polygonal column body, and the polygonal column body is operatively inserted into the polygonal clamping groove and is clamped with the polygonal clamping groove around the circumferential direction; the polygonal column body is provided with a guide hole along the axial direction, the guide hole and the driving tube are coaxially arranged, and the guide column is operatively inserted into the guide hole.
  11. 11. The annuloplasty repair device according to claim 10 wherein said engagement slot is a regular hexagonal engagement slot and said guide post is a regular hexagonal post.
  12. 12. The annuloplasty device according to claim 9, wherein said connecting portion is a rectangular cylinder having said guide hole formed therein; the clamping part is provided with a rectangular groove, and the rectangular groove can be sleeved outside the rectangular column body along the guide rope; the clamping part is also provided with a wiring hole along the axis direction, the wiring hole and the driving pipe are coaxially arranged, and the wiring hole is communicated with the rectangular groove.
  13. 13. The annuloplasty repair device according to claim 5 wherein said anchor sheath has bosses at axial ends, at least one of said bosses having said traction portion thereon, said bosses at both ends pressing against said projections on either side of said socket when said anchor sheath is disposed within said socket; the traction part on the boss is positioned on the inner side of the boss.
  14. 14. The annuloplasty repair device according to claim 13 wherein said anchor sheath further comprises a plurality of suture holes formed in a circumferential outer surface thereof, said suture holes being axially oriented in length, said suture holes extending through two of said bosses at opposite ends thereof.
  15. 15. The annuloplasty device according to claim 5 wherein said anchor is made of stainless steel medical material or nitinol.
  16. 16. A method of annulus repair comprising: releasing an annulus repair instrument at a preset position through a conveying system, guiding an anchor driver to enter a human body through a guide rope, clamping the anchor driver and an anchor of the annulus repair instrument along the circumferential direction, and screwing one or more anchors positioned at the side of a posterior leaflet atrioventricular groove into a posterior leaflet She Fangshi groove; pulling the pulling rope to gradually draw the rear valve leaflet towards the front valve leaflet, and fixing other anchors at the fiber muscle of the front valve leaflet when the annular shrinkage opening area reaches the preset opening and closing degree; withdrawing the guide rope and the traction rope.

Description

Annuloplasty device and method Technical Field The invention belongs to the technical field of medical appliances, and particularly relates to an annular repair appliance and a repair method. Background Clinical problem Congestive Heart Failure (CHF) is a complex disease that results in debilitation and death. After the initial injury typically includes ischemic, hypertensive or idiopathic factors, the heart suffers from muscle damage and transfers the load to the remaining healthy muscles. To compensate for this, the heart undergoes geometric remodeling, thereby increasing load and stress, causing further damage, forming a vicious circle. Mitral regurgitation associated with CHF is known as Functional Mitral Regurgitation (FMR), and is primarily caused by dilation of the mitral annulus along the small-septum lateral axis. When the ring expands, the leaflets fail to re-coapt and blood leaks or flows back into the atrium during systole. The heart compensates for regurgitation by working harder to maintain cardiac output. If left untreated, this will result in the heart being further stressed, muscle damage, and acceleration of congestive heart failure. Current practice generally involves direct annuloplasty and direct annuloplasty. Direct annulus repair is the use of an annulus repair device to secure the annular band to the mitral valve orifice by anchoring it to the myofiberboard layer over the annulus. The area of the flap opening is reduced by tightening the string inside the annular band. Or the corresponding points are respectively anchored at the front outer junction and the rear inner junction to be tightened to reduce the closing area of the flap opening. Typical instruments for direct annulus repair typically tighten the rope embedded in the tube after anchoring the polyurethane tube to the myofiberboard layer with anchors. However, the locking force of the later rope is easy to release and displace under the long-term vibration of the heart, so that the area of the ring opening is increased again. And the tail end of the tightening wire is cut off through a catheter with a wire cutting function after the rope is tightened, the tightening mode generates uneven circumferential stress on the mitral valve annulus, and the tail wire is broken and is easy to be infected due to exposure in a human body. Indirect annuloplasty is to reduce the annulus opening area by implanting a corresponding stent body within the great cardiac vein, expanding the great cardiac vein inside diameter, or by tensioning the rope at two anchor points near the fossa ovalis and the posterior leaflet (within the great cardiac vein, within the left atrial wall), respectively. However, the indirect annulus repair approach is not controllable for complications arising from the choice of anchor points for the anterior leaflet. For example, anchoring in great cardiac veins is preferred to create venous thrombosis, and the surgical procedure is irreversible. Disclosure of Invention The invention aims at solving the technical problem that the area of a ring opening is enlarged again due to easy loosening displacement generated by a rope tightening mode in the existing annular repair, in particular to the direct annular repair, and aims to provide an annular repair instrument and an annular repair method. An annuloplasty device comprising: a sleeve; the anchors are arranged on the sleeve and are sequentially arranged along the length direction of the sleeve; the shaping ring is made of a bendable and shaped shape memory material and is buried in the sleeve. Preferably, the shaping ring and the sleeve are integrally injection molded; and/or, the sleeve and the shaping ring adopt a C-shaped structure with a notch; and/or the sleeve is an elastic sleeve made of polyurethane or silica gel; the shaping ring is made of nickel-titanium alloy material; and/or, a plurality of developing rings are also arranged in the sleeve. Preferably, the sleeve is provided with a plurality of protruding parts along the circumference of the inner wall, the protruding parts are positioned on the inner side of the sleeve, and the protruding parts are provided with inserting ports for placing the anchors. Preferably, the anchor is provided with a threading hole; the annuloplasty device further comprises a traction rope which sequentially passes through the threading holes of each anchor along the circumferential direction of the sleeve. Preferably, the anchor comprises: an anchor body; the anchor pin jacket is axially provided with a through hole, an internal thread in threaded connection with the anchor pin body is arranged in the through hole, and the anchor pin jacket is arranged in the insertion port; and the traction part is provided with the threading hole. Preferably, the surface of the threading hole faces to the inner side of the sleeve. As a preferred scheme, the anchor body includes that connect gradually: a connecting portion provided with a guide hole